Integrated vascular device with puncture site closure component and sealant and methods of use

ABSTRACT

Apparatus and methods are provided for use in sealing a vascular puncture site. The invention comprises an integrated vascular device having a sheath with a closure component and puncture sealant. The closure component is disposed on and advanceable over the exterior of the sheath and may comprise any of a variety of apparatus suited for closing a vascular puncture. Once the closure component has been actuated to close the puncture, sealant is introduced to seal the puncture. The sheath and closure component are then removed from the patient.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.10/147,774, filed May 17, 2002, which is a continuation-in-part of U.S.patent application Ser. No. 09/478,179 filed Jan. 5, 2000, now U.S. Pat.No. 6,197,042, the disclosures of which are each incorporated byreference herein.

BACKGROUND OF THE INVENTION

1. The Field of the Invention

The present invention relates to apparatus and methods for sealing aniatrogenic puncture in a vessel formed in conjunction with a diagnosticor therapeutic treatment. More particularly, the present inventionprovides an integrated vascular device comprising a sheath having apuncture closure components and puncture sealant.

2. The Relevant Technology

Catheterization and interventional procedures, such as angioplasty andstenting, generally are performed by inserting a hollow needle through apatient's skin and muscle tissue into the vascular system. A guide wirethen is passed through the needle lumen into the patient's blood vessel.The needle is removed and an introducer sheath is advanced over theguide wire into the vessel. A catheter typically is passed through thelumen of the introducer sheath and advanced over the guide wire intoposition for a medical procedure. The introducer sheath thereforefacilitates insertion of various devices into the vessel whileminimizing trauma to the vessel wall and minimizing blood loss during aprocedure.

Upon completion of the medical procedure, the catheter and introducersheath are removed, leaving a puncture site in the vessel. Commonly,external pressure is applied until clotting and wound sealing occurs.However, this procedure is time consuming and expensive, requiring asmuch as an hour of a physician's or nurse's time, is uncomfortable forthe patient, and requires that the patient be immobilized in theoperating room, cathlab, or holding area. Furthermore, a risk ofhematoma exists from bleeding prior to hemostasis.

Various apparatus have been developed for percutaneously sealing avascular puncture by occluding or suturing the puncture site. Forexample, U.S. Pat. Nos. 5,192,302 and 5,222,974 to Kensey et al.describe the use of a biodegradable plug delivered through theintroducer sheath into the puncture site. When deployed, the plug sealsthe vessel and provides hemostasis. Such devices have been slow to gainacceptance in the medical community, however, due to difficultiesencountered in positioning the plug within the vessel.

Another previously known technique comprises percutaneously suturing thepuncture site with specialized apparatus. Such apparatus is described,for example, in U.S. Pat. No. 5,304,184 to Hathaway et al. Whilepercutaneous suturing devices may be effective, a significant degree ofskill may be required on the part of the practitioner. Because suchdevices are mechanically complex, they tend to be relatively expensiveto manufacture.

Surgical staples and resilient clips for external skin wound closure arewell known in the art. Examples include U.S. Pat. No. 5,026,390 to Brownand U.S. Pat. No. 5,683,405 to Yacoubian et al, which both describeresiliently deformable closure devices suitable for manual externalapplication.

To reduce the cost and complexity of percutaneous puncture closuredevices, such devices employing resilient or deformable clips have beendeveloped. U.S. Pat. No. 5,478,354 to Tovey et al. describes the use ofresilient clips in conjunction with a trocar to close abdominal puncturewounds. U.S. Pat. No. 5,810,846 to Virnich et al. describes aspecialized apparatus for closing a vascular puncture site with aplastically deformable clip. The apparatus preferably is advanced over aguide wire through a cannula to the surface of the puncture site, wherethe staple-like clips are delivered to close the wound.

U.S. Pat. No. 5,782,861 to Cragg et al. describes specialized apparatusfor closing a puncture site with a detachable clip. The apparatuscomprises a hollow shaft having a distal end formed with one or moreopposed pairs of resilient grasping prongs and that is advanced over aguide wire through a coaxial hollow tube to a position at the distal endof the tube just proximal of the puncture. The grasping prongs areextended beyond the distal end of the tube to grasp the vessel onopposing sides of the puncture. The shaft then is partially retracted,causing the prongs to contract within the tube, thereby sealing thepuncture site.

The use of backbleed indication as a positioning technique within avascular puncture is known. For example, U.S. Pat. No. 4,317,445 toRobinson describes a flashback chamber for providing visual indicationof venous entry of a cannula. However, that device does not discussvascular wound closure. U.S. Pat. No. 5,676,689 to Kensey et al., whichclaims priority from the U.S. Pat. No. 5,222,974 patent discussed above,uses a vessel location device to simplify positioning of thebiodegradable plug. The vessel locator enables blood from the vessel toflow there through so that the position of the vessel may be determined.However, the Kensey system only proffers one closure device, and thatdevice is complex and raises concerns about biocompatibility. It alsorequires the closure component to be positioned within the puncture,thereby increasing the likelihood of dangerous over-advancement of theplug into the vessel.

The percutaneous puncture closure devices described in the foregoingpatents generally have the drawback that they require relatively complexmechanisms and require time consuming manipulation to achievehemostasis. It therefore would be desirable to provide apparatus andmethods suitable for vascular puncture closure that overcome thesedisadvantages of previously known devices.

It also would be desirable to provide apparatus and methods that quicklyand effectively achieve hemostasis.

It further would be desirable to provide apparatus and methods whereinall foreign materials left in a patient's body are bioabsorbable.

It still further would be desirable to provide vascular puncture closureapparatus and methods that are safe, low cost, and easy to use.

BRIEF SUMMARY OF THE INVENTION

In view of the foregoing, it is an object of the present invention toprovide vascular puncture closure apparatus and methods that overcomedisadvantages of previously known devices.

It also is an object of this invention to provide apparatus and methodssuitable for vascular puncture closure that quickly and effectivelyachieve hemostasis.

It further is an object of the present invention to provide apparatusand methods wherein all foreign materials left in a patient's body arebioabsorbable.

It still further is an object of the present invention to providevascular puncture closure apparatus and methods that are safe, low cost,and easy to use.

These and other objects of the present invention are accomplished byprovided an integrated vascular device comprising a sheath having apuncture closure component and puncture sealant. The closure componentis disposed on and advanceable over the exterior of the sheath, whichmay, for example, comprise an introducer sheath, a trocar, or acatheter. The closure component may comprise any of a variety ofapparatus suited to close a vascular puncture. Once the closurecomponent has been actuated to close the puncture, sealant is introducedto the exterior surface of the closed puncture, preferably through thesheath's interior lumen, where the sealant seals the puncture closed.The sheath with closure component is then removed from the patient.

In a preferred embodiment constructed in accordance with the presentinvention, the closure component comprises a twist closure device. Thedevice pierces tissue surrounding the vascular puncture and then isrotated to close the wound. In an alternative embodiment, the closurecomponent comprises needles and an elastic segment surrounding theneedles. The needles pierce the puncture with the elastic segmentexpanded. The segment is then allowed to resiliently contract to anunstressed configuration of smaller diameter, thereby drawing theneedles together and closing the wound.

In a still further alternative embodiment, the needles, or prongs, areelastically deformed to an expanded diameter, in which they pierce thetissue adjacent to puncture. The needles then are allowed to resilientlycontract to an unstressed configuration of smaller diameter, therebyclosing the wound.

Sealant then may be introduced, preferably through the interior lumen ofthe sheath, to seal the puncture closed. The sealant may comprise any ofa variety of sealants, per se known, including adhesives, sutures, andclips, all of which are preferably bioabsorbable. Alternatively, theclosure component may further comprise the sealant, wherein the closurecomponent is left in place within the vessel until hemostasis naturallyoccurs, or wherein the closure component comprises a monopolar electrodeor opposed bipolar electrodes that cauterize the wound with RF current.In addition to cauterization, RF energy generates heat that beneficiallycauses shrinkage of the vascular tissue, thereby assisting closure ofthe wound. Thermal energy from electrical induction, infrared light,ultrasonic vibration, microwave or laser irradiation, and other meansmay also be used to seal the puncture.

Advantageously, the puncture closure component of the present inventionis inexpensively integrated into a sheath, thereby minimizing mechanicalcomplexity while providing quick, safe, effective, and easy-to-useapparatus for achieving vascular closure that overcomes drawbacks ofpreviously known devices. Methods of using the apparatus of the presentinvention also are provided.

BRIEF DESCRIPTION OF THE DRAWINGS

The above and other objects and advantages of the present invention willbe apparent upon consideration of the following detailed description,taken in conjunction with the accompanying drawings, in which likereference characters refer to like parts throughout, and in which:

FIG. 1 is a side view of a preferred embodiment of an integratedvascular device constructed in accordance with the present invention;

FIG. 2 is a side-sectional view of a sealing device for use with thevascular device of FIG. 1;

FIGS. 3A-3D are side views of the closure component of FIG. 1 in use ata vascular puncture site, shown in section, with the sealing device ofFIG. 2, illustrating a method of sealing the puncture site;

FIGS. 4A-4D are top views of the vascular puncture site of FIG. 3,corresponding to the side-sectional views of FIG. 3, furtherillustrating the method of FIG. 3;

FIGS. 5A-5C are side-sectional views of an alternative embodiment of anintegrated vascular device of the present invention in use at a vascularpuncture site, illustrating a method of sealing the puncture site;

FIGS. 6A-6E are side-sectional views of a further alternative embodimentin use at a vascular puncture site, illustrating a method of sealing thepuncture site; and

FIGS. 7A and 7B are isometric views of a section of vessel including andcorresponding to the vascular puncture site of FIG. 6, furtherillustrating the method of FIG. 6.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The integrated vascular sheath with closure component of the presentinvention overcomes disadvantages associated with previously knownmethods and apparatus for sealing a vascular puncture by providing aquick, simple, safe, low cost, effective, and easy-to-use solution towound closure. Apparatus constructed in accordance with the presentinvention provide vascular access and wound closure in a single device,eliminating the time and manipulation required to insert a separateclosure device at the completion of a procedure.

Referring to FIG. 1, a first embodiment of apparatus of the presentinvention is described. Vascular device 10 comprises sheath 12 coupledto hub 14, closure component 16, and closure actuator 18.

Sheath 12, which may, for example, comprise an introducer sheath, atrocar, or a catheter, includes central lumen 13 through which otherdevices may be introduced into the vasculature, for example, to performa diagnostic or interventional procedure such as angiography,angioplasty, or stenting, or to seal a puncture site.

Hub 14 is mounted on the proximal end of sheath 12 and includes sideport 20, arc lumens 22, and device port 24. Device port 24 communicateswith central lumen 13 of sheath 12, and has self-sealing elastomericmembrane 25 disposed across it. Self-sealing membrane 25, which maycomprise, for example, latex or a biocompatible synthetic rubber,permits interventional devices to be introduced through device port 24,while preventing blood loss through central lumen 13. Side port 20 ofhub 14 is also in communication with central lumen 13, and is connectedto hemostatic port 26 via biocompatible tubing 28.

In accordance with the principles of the present invention, closurecomponent 16 comprises lumen 30 that receives sheath 12. Component 16 isslidably disposed on the exterior of sheath 12 and is movable from astowed position, adjacent hub 14, to a distal deployment position, wheretines 17 of component 16 are urged into engagement with tissuesurrounding a vascular puncture. Closure component 16 comprises at leasttwo sharpened tips, or tines 17. Tines 17 preferably comprise backbleedports 32. Closure component 16 is rotatable within arc-lumens 22 aboutthe longitudinal axis of sheath 12, so that, with tines 17 engagingtissue surrounding the vascular puncture, component 16 closes thepuncture.

Closure actuator 18 comprises plunger 34 and tubes 36, which areconfigured to slidably pass through arc lumens 22 of hub 14. Theproximal ends of tubes 36 are coupled to backbleed bores 38 of plunger34. The distal ends of tubes 36 are mounted, either permanently ordetachably, in closure component 16, so that movement of plunger 34causes corresponding proximal or distal movement of closure component16. Likewise, rotation of plunger 34 causes corresponding rotation oftubes 36 within arc lumens 22, which, in turn, rotates closure component16 about the longitudinal axis of sheath 12.

Plunger 34 further comprises device bore 40, coaxially aligned withdevice port 24, and through which interventional devices or puncturesealants may be passed. As described in detail hereinafter, when plunger34 is moved to its proximal-most position, closure component 16 isdisposed adjacent to hub 14 and preferably provides adequate clearancefor interventional devices to be inserted through device port 24 andcentral lumen 13 into the patient's vasculature. When moved to itsdistal-most position, plunger 34 causes tubes 36 to urge closurecomponent 16 distally. Interventional devices or sealants then may beintroduced through device bore 40, device port 24, and central lumen 13into the vasculature.

Backbleed bores 38 of plunger 32 are in communication with backbleedlumens (not shown) within tubes 36. The backbleed lumens of tubes 36 arein communication with backbleed ports 32 of tines 17, therebyestablishing a complete backbleed path through ports 32, the lumens (notshown) of tubes 36, and bores 38. When tines 17 of closure component 16pierce a vessel wall surrounding a vascular puncture, blood entersbackbleed ports 32 and exits through backbleed bores 38, providingvisual confirmation to a surgeon that tines 17 are positioned within thevessel wall. The backbleed path thus enables the surgeon to determinewhen closure component 16 has been sufficiently advanced to permitrotation of component 16 to close the puncture, while reducing the riskthat component 16 is either short of the puncture site or is extendedinto the vessel.

In conjunction with closure of the puncture site caused by rotation ofcomponent 16, a puncture sealant may be introduced to the puncture siteto seal the site closed. The sealant may, for example, comprise anadhesive, such as a bioglue, tissue sealant, or clotting agent,delivered through hemostatic port 26, biocompatible tubing 28, side port20 and central lumen 13 of introducer sheath 12 to the vascular punctureto further help seal the vessel after puncture closure with closurecomponent 16. Alternatively, the adhesive may be delivered throughdevice port 24 or through the backbleed path described above. Instead ofadhesives, the closure component may further comprise the sealant,wherein the closure component is left in place within the vessel untilhemostasis naturally occurs. The sealant may also comprise suturesdelivered through central lumen 13. Additionally, the sealant maycomprise thermal energy application from, for example, electricalinduction, infrared light, ultrasonic vibration, microwave or laserirradiation, and other means.

With reference to FIG. 2, an alternative puncture sealing device inaccordance with the present invention is described. Sealing device 50comprises delivery device 52 and clip 54. Delivery device 52 comprisesproximal end 56 attached to tube 58. Tube 58 terminates at first jaw 60at its distal end and further comprises lumen 62 and pin 64. Pin 64extends into lumen 62 from an interior surface of tube 58 and isdisposed perpendicular to the longitudinal axis of tube 58.

Delivery device 52 further comprises second jaw 66 having femaleconnector 68 coupled to pin 64, so that second jaw 66 pivots about pin64. Second jaw 66 further comprises moment arm 70. Tension spring 72 iscoupled to moment arm 70 and to the interior surface of tube 58 in amanner that biases second jaw 66 against first jaw 60.

First jaw 60 and second jaw 66 preferably form channel 74 when biasedagainst one another. Channel 74 is configured to receive clip 54. Thebiasing force applied by tension spring 72 holds clip 54 within channel74, so that the clip may be advanced into tissue surrounding a vascularpuncture that has had its edges approximated by closure component 16(FIG. 1).

Delivery device 52 still further comprises plunger 76 coupled to pushrod78 having release arm 80. Pushrod 78 is received within lumen 62 of tube58, so that release arm 80 engages moment arm 70.

Distal advancement of pushrod 78, via application of force to plunger76, causes release arm 80 to urge moment arm 70 distally. This motionovercomes the biasing force applied by tension spring 72 and causessecond jaw 66 to pivot about pin 64. Second jaw 66 thus no longercontacts first jaw 60, and clip 54 is released from channel 74. Tube 58,first jaw 60, second jaw 66, and clip 54 of sealing device 50 preferablyare sized for introduction into a patient's vasculature through devicebore 40, device port 24, and lumen 13 of vascular device 10.

Referring to FIGS. 3A-3D through 4A-4D, in conjunction with FIGS. 1 and2, a method of using vascular device 10 with sealing device 50 isdescribed. Sheath 12 is advanced through skin, fat, and muscle tissueinto vessel V, through the vessel wall tissue surrounding vascularpuncture P. With plunger 34 and tubes 36 of actuator 18 in theproximal-most, fully retracted position, an interventional procedure isperformed by introducing one or more interventional devices, e.g.angioplasty balloons, stent delivery systems, atherectomy devices, etc.,through device port 24 and lumen 13 of sheath 12, in accordance withwell-known techniques. Side port 20 may be used to infuse fluids, e.g.,contrast agents or medications, into the vessel through sheath 12 duringthe interventional procedure.

Upon completion of the procedure, vascular device 10 may beadvantageously used to close vascular puncture P. At this point, closureactuator 18 and closure component 16 are disposed in the proximal-mostposition, with component 16 adjacent to hub 14. Closure actuator 18 isadvanced by urging plunger 34 in the distal direction, thus causingtubes 36 to slide through arc lumens 22 of hub 14 and advance closurecomponent 16.

As seen in FIG. 3A, continued distal advancement of plunger 34 causestines 17 at the distal end of closure component 16 to pierce tissuesurrounding puncture P, so that the backbleed ports 32 of tines 17directly communicate with the puncture wound. Tine punctures T in FIG.4A represent the points at which tines 17 enter vessel V. The presenceof pressure in the vessel higher than atmospheric pressure causes bloodto pass through backbleed ports 32, through the backbleed lumens (notshown) of tubes 36, and exit through the proximal ends of backbleedbores 38, thus confirming that tines 17 have engaged tissue around thepuncture site and should not be advanced further.

In FIG. 3B, sheath 12 is removed from puncture P to facilitate closureof the puncture. Closure actuator 18 is held stationary while hub 14 iswithdrawn proximally, thereby withdrawing sheath 12 proximally frompuncture P. The puncture remains open, as seen in FIG. 4B. With sheath12 no longer within puncture P, closure actuator 18 is rotated withinarc lumens 22 to rotate closure component 16. Rotation of closurecomponent 16 causes tines 17 to rotate and urge the puncture closed, asseen in FIGS. 3C and 4C.

Upon closure of puncture P, a sealant is introduced to seal the woundclosed. The sealant may, for example, comprise an adhesive, such as abioglue, tissue sealant, or clotting agent, it may comprise a suture, itmay comprise thermal energy application, or it may comprise leaving theclosure component in place within vessel V until hemostasis naturallyoccurs. Alternatively, the sealing device may comprise a clip, asdescribed hereinafter.

FIGS. 3D and 4D show apparatus 10 used in conjunction with sealingdevice 50 of FIG. 2. With clip 54 disposed in channel 74 of deliverydevice 52, the delivery device is delivered to vessel V through devicebore 40 of closure actuator 18, device port 24 of hub 14, and centrallumen 13 of sheath 12. Clip 54 punctures the vessel at tissuesurrounding closed puncture P, creating clip punctures C and sealing thepuncture. Pushrod 78 of delivery device 52 is then actuated to separatesecond jaw 66 from first jaw 60 to release clip 54 from delivery device52. Apparatus 10 and delivery device 52 are removed from the patient tocomplete the procedure. Clip 54 maintains closure until hemostasisoccurs and is preferably bioabsorbable so that no foreign materials arepermanently implanted in the patient's body. Additional clips may alsobe implanted, as required.

With reference now to FIGS. 5A-5C, an alternative integrated vasculardevice in accordance with the present invention is described. Apparatus100 comprises sheath 102 coupled to hub 104, closure component 106, andclosure actuator 108.

Like sheath 12, sheath 102 may, for example, comprise an introducersheath, a trocar, or a catheter, and includes central lumen 103 throughwhich other devices may be introduced into the vasculature, for example,to perform a diagnostic or interventional procedure such as angiography,angioplasty, or stenting, or to seal a puncture site. Hub 104 comprisesbore 110, which slidably receives actuator 108, and device port 112,which is in communication with central lumen 103 of sheath 102 andpermits introduction of interventional devices while preventing bloodloss through central lumen 103. Hub 104 further comprises side port 114.

Closure component 106 comprises outer housing 116 having lumen 118configured to slidably receive sheath 102, bore 120 for slidablyreceiving inner housing 122, lumen 124 adapted to receive closureactuator 108, and needles or prongs 126 with sharpened tips 128. Innerhousing 122 has lumen 123 adapted to receive sheath 102 and channels 130adapted to receive prongs 126. Component 106 comprises at least twoprongs 126, and preferably comprises four.

Closure actuator 108 comprises actuation tube 132 having lumen 133,actuation rod 134 disposed within actuation tube 132, first plunger 136coupled to the proximal end of tube 132, and second plunger 138 coupledto the proximal end of rod 134. The distal end of tube 132 is affixed,either permanently or detachably, in lumen 124 to outer housing 116 ofclosure component 106, while the distal end of rod 134 is coupled toinner housing 122.

To perform an interventional procedure through central lumen 103 ofsheath 102, the sheath is advanced through skin, fat, and muscle tissueinto vessel V, through vascular puncture P, in accordance withwell-known techniques. With closure component 106 in the proximal-most,fully retracted position adjacent hub 104, the interventional procedurethen is performed by introducing one or more interventional devices,e.g. angioplasty balloons, stent delivery systems, atherectomy devices,etc., through device port 112 and lumen 103 of sheath 102, again inaccordance with well-known techniques. Side port 114 may be used toinfuse fluids, e.g., contrast agents or medications, into the vesselthrough sheath 102 during the interventional procedure.

Upon completion of the procedure, apparatus 100 advantageously may beused to close the vessel. Closure component 106 is advanced distally byurging plungers 136 and 138 distally. Inner housing 122 is onlypartially received within bore 120 of outer housing 116 so that prongs126 are elastically deformed and received within channels 130. As shownin FIG. 5A, closure component 106 is advanced until inner housing 122abuts against the vessel V, as may be determined, for example, with abackbleed indicator (not shown).

In FIG. 5B, first plunger 136 is urged distally to distally advanceactuation tube 132 and outer housing 116, while second plunger 138 andsheath 102 are held stationary. Advancement of outer housing 116advances sharpened tips 128 of prongs 126 into tissue surroundingpuncture P.

In FIG. 5C, sheath 102 and second plunger 138 are retracted proximallyto draw sheath 102 out of vessel V and to draw inner housing 122completely within bore 120 of outer housing 116. Proximally retractinginner housing 122 via actuation rod 134 and second plunger 138 removesprongs 126 of outer housing 116 from channels 130 of the inner housing.The prongs resiliently contract to a lower stress configuration, therebydrawing opposing sides of puncture P together and closing the wound. Asealant, for example clip 54 of FIG. 2, may then be introduced to theclosed puncture to seal the site closed, as discussed hereinabove.Alternatively, the sealing device may comprise RF current, supplied byan RF generator (not shown), applied across opposed tips 128, which actas bipolar electrodes.

Referring to FIGS. 6A-6E, as well as FIGS. 7A and 7B, a still furtheralternative embodiment of apparatus of the present invention isdescribed. FIG. 6 depict the closure component of an integrated vasculardevice in use at vascular puncture P within vessel V. Apparatus 150comprises sheath 152 coupled to a hub (not shown), closure component154, and a closure actuator (not shown). Various closure actuators foruse with closure component 154 will be apparent to those of skill in theart from the foregoing embodiments.

Sheath 152 may, for example, comprise an introducer sheath, a trocar, ora catheter, and includes central lumen 153 through which other devicesmay be introduced into the vasculature, for example, to perform adiagnostic or interventional procedure such as angiography, angioplasty,or stenting, or to seal a puncture site. Closure component 154 comprisesspacer 156, needles 158, and needle cover 160. Spacer 156 is coaxiallyand slidably disposed about the exterior of sheath 152, and preferablyhas an annular diameter of about 1 mm to ensure that needles 158 engagethe tissue surrounding puncture P rather than enter the puncture, sothat the needles are able to draw the wound closed, as describedhereinbelow. Needles 158 are disposed between spacer 156 and cover 160during advancement to puncture P. Needles 158 comprise ledges 162, whichact as positive stops to prevent excessive advancement of the needleswith respect to cover 160, which comprises corresponding annular ledge164. Cover 160 further comprises elastic segment 166, configured toelastically deform needles 158. Closure component 154 comprises at leasttwo needles 158, and preferably comprises four. Needles 158 may furthercomprise retaining means (not shown), such as barbs or hooks, to assistin gripping tissue.

As shown in FIG. 6A, sheath 152 may be advanced through skin, fat, andmuscle tissue into vessel V, through vascular puncture P, in accordancewith well-known techniques. With closure component 154 in aproximal-most, fully retracted position adjacent the hub, aninterventional procedure is performed through central lumen 153 ofsheath 152 by introducing one or more interventional devices through thelumen into the patient's vasculature. Closure component 154 then isadvanced via the closure actuator until it abuts against vessel V, asmay be determined, for example, with a backbleed indicator, such asdescribed for the foregoing embodiments. Cover 160 protects needles 158and prevents snagging of tissue as closure component 154 is distallyadvanced down sheath 152 and through skin, fat, and muscle tissue.Spacer 156 retains needles 158 in a position away from the edge ofpuncture P.

In FIG. 6B, needles 158 are distally advanced with respect to needlecover 160 until ledge 162 abuts ledge 164. Needles 158 deflect elasticsegment 166 of cover 160 outward and pierce tissue surrounding punctureP. FIG. 7A depicts, in isometric view, the segment of vessel Vsurrounding puncture P. With a needle arrangement comprising fourneedles 158, the needles create needle punctures N surrounding vascularpuncture P. Sheath 152 and spacer 156 then are retracted proximally andremoved from vessel V, as shown in FIG. 6C. As depicted in FIGS. 6D and7B, elastic segment 166 of needle cover 160 resiliently contracts,thereby drawing needles 158 together and approximating the edges of thewound.

A sealant, such as a bioglue, tissue sealant, or clotting agent, thenmay be introduced to the puncture site to seal the wound closed.Alternatively, closure component 154 may be maintained in position untilhemostasis occurs naturally, or sutures may be introduced throughcentral lumen 153. In addition, or in the alternative, RF energy may beapplied across needles 158, as described hereinabove with respect toFIG. 5, or a clip, such as clip 54 of sealing device 50 of FIG. 2, maybe applied. Thermal energy from electrical induction, infrared light,ultrasonic vibration, microwave or laser irradiation, and other meansmay also be used to seal the puncture.

Illustratively, FIG. 6E depicts sealing device 170, comprising adhesive172, being delivered through central lumen 153 within delivery sheath174. After sufficient time for adhesive 172 to set, apparatus 150 isremoved from vessel V.

Although preferred illustrative embodiments of the present invention aredescribed hereinabove, it will be evident to one skilled in the art thatvarious changes and modifications may be made without departing from theinvention. It is intended in the appended claims to cover all suchchanges and modifications that fall within the true spirit and scope ofthe invention.

1. A method of closing an opening in tissue, comprising: disposing asheath within a tissue tract, wherein a distal end of the sheath isdisposed within an opening formed in tissue; performing a medicalprocedure through a lumen of the sheath; closing the opening with aclosure component, the closure component comprising at least twosharpened tips for engagement with tissue adjacent the opening, thesharpened tips having an expanded delivery configuration and a retracteddeployed configuration to close the opening; and applying a sealingmeans to the opening to effect closure of the opening.
 2. The methodaccording to claim 1, wherein the step of applying a sealing meanscomprises applying a sealing means selected from a group consisting ofRF energy, thermal energy, electrical induction, infrared light,ultrasonic vibration, microwave or laser irradiation, clips, sutures, oradhesives.
 3. The method according to claim 1, further comprising thestep of delivering a sealant to the opening.
 4. The method according toclaim 1, further comprising the step of disposing a clip adjacent theopening to further seal the opening closed.
 5. The method according toclaim 1, wherein the closing step further comprises rotating the closurecomponent after engaging the sharpened tips with the tissue.
 6. Themethod according to claim 1, wherein the sharpened tips are associatedwith elastically deformed prongs.
 7. The method according to claim 6,wherein the step of closing the opening further comprises moving amember within the closure component proximally to enable the elasticallydeformed needles to resiliently contract.
 8. A method of closing anopening in tissue, comprising: disposing a sheath within a tissue tract,wherein a distal end of the sheath is disposed within an opening formedin tissue; performing a medical procedure through a lumen of the sheath;positioning a closure component to close the opening, the closurecomponent comprising at least two sharpened tips for engagement withtissue adjacent the opening, the sharpened tips having an expandeddelivery configuration and a retracted deployed configuration; closingthe opening formed in the tissue; and applying a sealing means to theopening to effect closure of the opening.
 9. The method according toclaim 8, wherein positioning the closure component comprises sliding theclosure component along the sheath until the at least two sharpened tipsengage with tissue.
 10. The method according to claim 8, wherein closingthe opening comprises moving a member within the closure componentproximally to move the at least two sharpened tips towards one another.11. The method according to claim 8, wherein closing the openingcomprises rotating the closure component after engaging the at least twosharpened tips with the tissue.
 12. A method of closing an opening intissue, comprising: disposing a sheath within a tissue tract, the sheathcomprising a proximal end, a distal end disposable within an openingformed in tissue, and a lumen extending from the proximal end toward thedistal end; performing a medical procedure through the lumen of thesheath; positioning a closure component upon the tissue adjacent to theopening, the closure component comprising at least two sharpened tipsfor engagement with tissue, the sharpened tips having an expandeddelivery configuration and a retracted deployed configuration; closingthe opening formed in the tissue; and applying a sealing means to theopening to effect closure of the opening.
 13. The method according toclaim 12, wherein applying the sealing means comprises: disposing asealing device, which supports a clip, through the lumen of the shaft;deploying the clip from the sealing device to effect closure of theopening.
 14. The method according to claim 13, wherein disposing thesealing device comprises moving the sealing device through the lumenuntil at least two sharpened tips of the clip contacts the tissue. 15.The method according to claim 13, further comprising delivering asealant to the opening.
 16. The method according to claim 13, whereinthe sealing device comprises a first jaw and a second jaw pivotalrelative to the first jaw, the first jaw and the second jaw selectivelyretaining the clip.
 17. The method according to claim 15, whereindeploying the clip comprises moving the second jaw relative to the firstjaw to release the clip.
 18. The method according to claim 13, whereinclosing the opening comprises moving a member within the closurecomponent proximally to move the at least two sharpened tips towards oneanother.
 19. The method according to claim 18, wherein the at least twosharpened tips are associated with elastically deformed needles, andwherein moving the member releases the elastically deformed needles andmoves the at least two sharpened tips towards one another.
 20. Themethod according to claim 13, wherein closing the opening comprisesrotating the closure component after engaging the at least two sharpenedtips with the tissue.